PMA P990023S010

Device
CELLUGEL
Applicant
Alcon Laboratories
PMA number
P990023
Supplement
S010
Product code
LZP
Decision date
2010-11-10
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
EXPANSION OF THE CURRENTLY APPROVED CLEANROOM (INCLUDING AN OFFICE AREA) AND THE ADDITION OF A NEW MATERIAL LOCK FOR OVD MANUFACTURING PROCESSES.

Current openFDA PMA Record#

Device
CELLUGEL
Applicant
Alcon Laboratories
PMA number
P990023
Supplement
S010
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2010-11-10
Decision code
OK30
Date received
2010-10-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
EXPANSION OF THE CURRENTLY APPROVED CLEANROOM (INCLUDING AN OFFICE AREA) AND THE ADDITION OF A NEW MATERIAL LOCK FOR OVD MANUFACTURING PROCESSES.